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The Relationship of Fabric Properties and Bacterial Filtration Efficiency for


Selected Surgical Face Masks

Article · January 2003

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Volume 3, Issue 2, Fall 2003

The Relationship of Fabric Properties and Bacterial Filtration Efficiency for


Selected Surgical Face Masks

Karen K. Leonas, Ph.D. and Cindy R. Jones


Dawson Hall, University of Georgia
Athens, Georgia 30602

ABSTRACT

Surgical face masks are an important component of surgical apparel. The masks are expected to
perform as barriers and provide increased protection to the patients and health care workers. In
this study, the Bacterial Filtration Efficiency (BFE) of six commercially available surgical face
masks was determined for two microorganisms. Fabric characteristics (weight, thickness, pore
size, and resistance to synthetic blood strike through) thought to influence the barrier
effectiveness were measured and the relationship between these characteristics and BFE was
examined. Two challenge microorganisms, Staphylococcus aureus and Escherichia coli were
evaluated in this study. For five of the six masks evaluated, the BFE against the challenge
microorganism S. aureus was higher than when the challenge microorganism was E. coli. The
mask with the lowest mean pore size and lowest maximum pore size had the highest BFE for both
microorganisms evaluated, indicating that a relationship exists between pore size and BFE.

Keywords: surgical face masks, bacterial filtration efficiency, S. aureus, E. coli

Introduction: identified as “Surgical Apparel” in 21 CFR,


Part 878.4040. The OSHA Occupational
Bacterial and viral diseases are spread Exposure to Blood Borne Pathogens: Final
through both airborne and blood borne Rule (1991) mandates the principles of
pathways in the operating theater. Surgical universal precautions, mandates
apparel can minimize the transmission of performance levels, and allows employers to
disease. The transfer of microorganisms can specify what personal protective equipment
be reduced because the protective surgical is required and when it must be used.[2, 3]
apparel creates a physical barrier between Surgical face masks are an important
the infection source and the healthy component of surgical apparel. The masks
individual.[1] A medical device intended to are expected to perform as barriers and
be worn by operating room personnel during provide increased protection to the patients
surgical procedures to protect both the and health care workers. Initially, the
surgical patients and operating room primary purpose of the facemask was to
personnel from transfer of microorganisms, protect the patient from being contaminated
body fluids and particulate material is by bacteria or viral species exhaled or
Article Designation: Refereed 1 JTATM
Volume 3, Issue 2,Fall 2003
expelled from the health care worker. protective eyewear whenever exposures to
Normal activities such as sneezing, mucous membranes is reasonably
coughing, shouting, crying, breathing and anticipated.[14] The Operating Room
speaking may release oral, dermal and Nurses Association of Canada (ORNAC)
nasopharyngeal bacteria that may cause agree with these recommendations.[15]
post-operative infections.[4] A second The CDC guidelines admit that the role of
purpose of the mask, that has emerged in the face masks in reducing the risk of surgical
past decade, is the protection for the health site infections may be more uncertain than
care worker from exposure to blood borne previously thought. And yet, the same
pathogens. Skinner and Sutton have guidelines support the use of surgical face
reported studies that show how surgeons masks as personal protective equipment.
commonly receive blood and/or fluid
splashes to the face during operating room In this regard the study of the transmission
procedures.[5] of small particles and liquid aerosols
through nonwoven products used in
In the past decade, a number of publications protective apparel and other filter media is
have addressed the development and role of of importance. This area of study, with
the surgical face mask in the operating reference to surgical face masks, is of
theater, and its effectiveness in reducing interest as masks are now expected to act as
post-operative infections.[5, 6, 7, 8, 9, 10] protective barriers. In the summer of 2001,
Research has shown that there are numerous several new ASTM standards specifically
other methods by which bacteria become relating to face masks and their evaluation
airborne and that the microorganisms shed (ASTM-F2101-01; ASTM-F2100-01) were
by the healthcare team are the most approved.[16] In a draft document,
significant contaminating agents, even in published in 1998, the FDA listed 5 major
correctly designed operating rooms.[5] categories of tests that are available for
Studies have also shown that the fit of the determining the barrier performance and
mask, the proper positioning and use of the safe use of a surgical mask. They were 1)
mask, movement by the wearer, the length fluid resistance, 2) filtration efficiency, 3)
of facial hair and voice level when speaking, air exchange pressure (Delta P), 4)
all have a direct bearing on its filtering flammability and 5) biocompatibility
efficiency.[11, 12, 13] testing.[17]

Although the effectiveness of the face mask In 1999 Davis reviewed the test methods
for reducing surgical site infections has been used for the evaluation of face masks
controversial, a number of major effectiveness [18]. Bacterial Filtration
organizations have published guidelines for Efficiency (BFE), both in vivo and in vitro,
health care workers to minimize risks of is a widely accepted method of evaluating
exposure which include face masks. They face masks. In these tests, the bacteria
include the Centers for Disease Control penetrating the face masks are collected,
[CDC], Association of Operating Room cultured and counted to determine the
Nurses [AORN], Occupational Safety and number of Colony Forming Units (CFU’S)
Health Administration [OSHA] and the that penetrate the mask. The in vitro test
Operating Room Nurses Association of uses positive and negative controls to
Canada [ORNAC]. AORN recommends determine the initial number of bacteria.
that “all persons entering restricted areas of The challenge bacteria are contained in a
the surgical suite should wear mask when mist, which is produced by aerosolizing the
open sterile items and equipment are bacteria with 0.1% peptone water in a
present” and that masks be worn along with nebulizer. The masks are placed directly
Article Designation: Refereed 2 JTATM
Volume 3, Issue 2,Fall 2003
over the opening of an Anderson sampler. measured and evaluated. Although the fit
The aerosol consists largely of droplets that of the mask and leaks between the face and
simulate expulsion from the wearer. The the mask interface are known to be
current BFE tests are used with the important performance considerations, they
microorganism S. aureus. However there have not been addressed in this study.
are a number of microorganisms in addition
to S. aureus that are known to cause Materials and Methods:
nosocomial infections and other serious
health problems. Nosocomial infections, In this study, two components of the FDA
which are defined as those infections recommended areas were evaluated, 1)
originating in the hospital or healthcare liquid resistance and 2) filtration efficiency.
center, occur in about 5% of all patients Six commercial face masks, each from a
admitted to the hospital, with 41% being different manufacturer, were selected for
urinary tract infections, 18% surgical, and evaluation (Table 1). Three of the face
16% respiratory.[19] Postoperative wound masks (#1-3) were three ply with a pleated
infections occur in up to seven percent of construction, and three (#4-6) were molded
surgical patients and require patients to face masks.
remain in the hospital an average of 7.3
extra days at an additional average cost of Properties that characterize the fabric, such
$3,152.[20, 21] Although a variety of as thickness, weight, and pore size, were
pathogens are encountered in the hospital measured in addition to the liquid resistance
environment, a relatively limited number and bacterial filtration efficiency. These
cause the majority of hospital infections characteristics were determined in
including Escherichia coli, Pseudomonas accordance with standard testing procedures
aeruginosa, Enterococcus faecalis, Candida (Table 2). Liquid barrier properties were
albicans, and Staphylococcus aureus.[20] measured according to ASTM F-1862-98:
Standard Test Method for Resistance of
Microorganisms have varying characteristics Medical Face Masks to Penetration by
that can influence their potential ability to Synthetic Blood. This test method is
penetrate the facemask material including designed to evaluate penetration of the
shape, size, and their surface characteristics. masks by synthetic blood under high
A wide variety of studies have evaluated the velocity. In this project varying degrees of
BFE of face masks, however there have velocity were examined to determine the
been a limited number of microorganisms influence of pressure on the level and
evaluated in these studies.[4,22,23] mechanism of transmission. Velocity spray
Willeke, et. al reported that rod-shaped pressures of 80 mmHg, 120 mmHg, and 160
bacteria penetrate less than spherically mmHg were selected.
shaped bacteria of similar size.[22] In
addition, few studies have evaluated the The Bacterial Filtration Efficiency for each
BFE of the face masks with specifically mask was determined in accordance with
engineered fabric characteristics ASTM Test Method F2101-01, Evaluating
the Bacterial Filtration Efficiency (BFE) of
In this study, the BFE of six commercially Medical Face Mask Materials, Using a
available surgical face masks was Biological Aerosol of Staphylococcus
determined for two microorganisms, S. aureus. Two bacteria were selected for
aureus and E. coli. Fabric characteristics evaluation in this study, S. aureus and E.
that influence the barrier effectiveness were coli.

Article Designation: Refereed 3 JTATM


Volume 3, Issue 2,Fall 2003
Table 1: Face masks Descriptions

Mask Name Description

1 Tie-on Surgical Face Mask 3-ply, pleated rayon outer web with polypropylene inner
web

2 Classical Surgical Mask, Blue 3-ply, pleated cellulose polypropylene, polyester

3 Sofloop Extra Protection Mask 3-ply, pleated blended cellulosic fibers with polypropylene
and polyester, ethylene methyl acrylate strip

4 Aseptex Fluid Resistant Molded rayon and polypropylene blend with acrylic binder

5 Surgine II Cone Mask Molded polypropylene and polyester with cellulose fibers

6 Surgical Grade Cone Style Mask Molded polypropylene

Table 2. Test Methods and Procedures Used to Determine Facemask Properties

Description Method Number Title


Thickness ASTM D1777-96 Standard Test Method for Thickness of Textile Materials
Weight ASTM D3776 -96 Weight Per Unit Area
Pore Size PMI Automated Perm Porometer Operation Manual, Version 6.
Synthetic Blood Standard Test Method for Resistance of Medical Face Masks to
ASTM F1862-00a
Resistance Penetration by Synthetic Blood

Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face


Bacterial Filtration
ASTM F2101-01 Mask Materials, Using a Biological Aerosol of Staphylococcus
Efficiency
aureus.

S. aureus is a gram positive cocci that is The percent BFE was determined as
irregular in shape and often in grape like described in the test method for S. aureus,
clusters. Various diseases and ailments and modified for E. coli. The S. aureus was
including impetigo, toxic shock syndrome, obtained from American Type Culture
food poisoning and pneumonia are attributed Collection #6538 and E. coli was obtained
to S. aureus. An average coccus is about 0.5 from UGA Microbiology Department.
- 1.0 µm in diameter. E. coli is a gram Tryptic Soy Agar was the media used and
negative, rod shaped bacteria and averages Peptone water (Difco Dehydrated 500
1.1 to 1.5 µm in width by 2.0 to 6.0 µm in grams-Lot #1361000) was used as the
length. E. coli is a leading cause of urinary diluting agent as needed for the test method.
tract infections. Positive and negative controls were
Article Designation: Refereed 4 JTATM
Volume 3, Issue 2,Fall 2003
completed for each replication as directed in for Mask #6. The molded masks (#4, 5 & 6)
the test method. Using the positive control, were significantly higher in weight than the
it was determined that a challenge delivery pleated masks (#1, 2 & 3).
rate of 2200 +/- 500 viable particles per test
was required. This was achieved by diluting The percent Bacterial Filtration Efficiency
the bacterial stock solution to the for each mask and bacteria are presented in
appropriate bacterial concentration. The rate Table 4. For 5 of the 6 masks (not Mask
was determined by the results of the positive #4), the BFE values were higher when tested
control plates when the aerosol is collected with E. coli than for S. aureus. This was
in the six-stage viable particle cascade expected as the size and shape of the
impactor, with no test specimen clamped microorganisms differ and E. coli is larger
into the test system. The exposed plates and rod shaped when compared with S.
were placed in an incubator at 37oC for 24 aureus. S. aureus ranges in size from 0.5 to
hours. The CFU’s for each plate were 1.0 microns and is round in shape. E. coli is
counted using the Protocol Bacteria Colony rod shaped and averages 1.1 to 1.5 µm in
Counter, Synopitcs Corporation, V 2.05. width by 2.0 to 6.0 µm in length.
The filtration efficiency percentages were
calculated using the equation provided in the Mask #3 had the highest %BFE for S.
test method: aureus and the second highest %BFE for E.
coli and the lowest mean pore size of the
100 (C-T) / C = %BFE face masks examined here. This indicates a
relationship between pore size and BFE and
where C = average plate count total for test further testing should be completed to
controls and T = plate count total for test investigate this relationship.
sample.
Mask #3, also had the lowest maximum pore
Results and Discussion size of 27.19 µm. This is a critical
parameter to measure as this indicates the
The fabric characterization results for the largest pore detected in the sample and
three face masks are presented in Table 3. therefore particles may be transmitted
The pleated masks had lower pore size through this opening, hence reducing the
means than the molded masks. Mask #3 had BFE. When considering the mean pore size
the lowest mean pore size, 16.9µm, followed and the maximum pore size for face Masks
by Mask #2 with a mean pore size of #1 and #2, their order from highest to lowest
19.29µm, and Mask #1 had the highest pore is reversed for these two parameters.
size of the pleated masks at 23.97 µm. The Although Mask #2 had a lower mean pore
mean pore size of the molded masks were size than Mask #1, the maximum pore size
significantly higher ranging from 31.72 µm was greater than that of Mask #1. This may
(Mask #6) to 51.0 µm (Mask #5). Although help explain why the BFE for the masks is
thickness was not significantly different for not in the same order as the mean pore size.
the masks, the basis weight ranged from Mask #2 had a slightly lower BFE for E. coli
58.567 gm/m2 (Mask #2) to 164.405 gm/m2 (98.53%) and S. aureus (88.18%) than did

Article Designation: Refereed 5 JTATM


Volume 3, Issue 2,Fall 2003
Table 3: Face Mask Material Characteristics- thickness, weight, pore size, Resistance to
Blood

Pore Size Synthetic Blood Resistance


Thickness Weight µm (% Passed)
Mask mm gm/m2 Mean Max. 80 mm 120 mm 160 mm
Hg Hg Hg
1 0.3345 66.908 23.97 41.74 70 0 0

2 0.2339 58.657 19.29 43.27 100 100 50

3 0.4417 95.775 16.90 27.19 100 100 100

4 0.6137 140.828 35.06 87.74 0 0 0

5 0.3607 145.760 51.00 146.60 0 0 0

6 0.4742 164.405 31.72 92.12 0 0 0

Table 4. Face Mask Bacterial Filtration Efficiency - Mean and (Standard Deviation)

Mask S. aureus - % BFE E. coli - % BFE


1 91.09 98.53
(0.08) (0.01)
2 88.18 97.26
(0.04) (0.01)
3 92.19 99.34
(0.03) (0.01)
4 90.72 99.10
(0.03) (0.01)
5 84.82 95.74
(0.01) (0.03)
6 86.4 99.73
(0.05) (0.00)

Mask #1 (E. coli, 97.26%; S. aureus CONCLUSIONS


88.18%). The % BFE for Mask #4 for S.
aureus was higher than for Mask #2, which The BFE of six surgical face masks has been
was unexpected since the mean and measured by challenges from two
maximum pore size for Mask #2 was lower. microorganisms, S. aureus and E. coli.
Although there were no significant
differences between the face masks, the

Article Designation: Refereed 6 JTATM


Volume 3, Issue 2,Fall 2003
bacterium did have a significant influence 8. Romney, M.G., (2001). Journal of
on the facemask performance. The BFE for Hospital Infection, Vol. 47, No. 4, pp. 251-
5 of the 6 masks exposed to E. coli was 256.
higher than when exposed to S. aureus. This 9. Tunevall, T.G. (1991). World Journal of
was likely due to the size and shape of the Surgery. Vol 15, pp. 383 - 388.
bacteria. S. aureus is round and ranges in 10. Lipp A. and Edwards, P., (2002). The
size from 0.5mm to 0.1 mm. E. coli is rod Cochrane Library, Volume (Issue) 4, 2002.
shaped and is larger, with size ranging from 11. Koch, F., (1996). Infection Control and
1.1 to 1.5 µm in width and from 2.0 to 6.0 Sterilization Technology, 2, pp 15-17.
µm in length. Continuing studies with 12. McLure, H.A., Mannam, M., Talboys,
different microorganisms and face masks C.A., Azadian, B.S. and Yentis, M.S.,
with varied characteristics will provide (2000). Anesthesia, Vol. 55, No. 2, pp. 173-
additional information on those factors that 176
influence facemask barrier performance. In 13. McLure, H.A. , Talboys, C.A., Yentis,
addition, the relationship between the mean S.M., and Azadian, B.S., (1998).
pore size, the maximum pore size and the Anesthesia, Vol 53, No. 7, pp. 624-626
pore size distribution with BFE performance 14. Association of Operating Room Nurses
should also be examined. (AORN) Recommended Practices
Committee, (1998). AORN Journal, Vol. 68,
ACKNOWLEDGMENTS No. 6, pp.1048-1052.
15. Operating Room Nurses Association of
This research was funded in part through a Canada (ORNAC). Recommended
grant from the Georgia Agricultural standards for perioperative nursing practice.
Experiment Station, regional project S-1002. 4th ed. 1998.
16. Annual Book of ASTM Standards,
REFERENCES 2002, American Society for Testing and
Materials, West Conshohocken, PA, 2002.
1. Goldmann, D.A., (1991). Journal of 17. “Guidance on the Content and Format of
Hospital Infection, 18 (Supplement A), pp. Premarket notification [510(k)] Submission
515-523. Surgical Mask, Draft. Infection control
2. Occupational Safety & Health Devices Branch Division of Dental,
Administration. (1991, December 6). Infection Control and General Hospital
Federal Register, 56, 64004-64182 (29 CFR Devices, Office of Device Evaluation Center
Part 1910.1030), 1991, December 6. for Devices and Radiological Health, Food
3. Centers for Disease Control. (1987). and Drug Administration, January 16, 1998.
Morbidity & Mortality Weekly Report, Vol. 18. Davis, W. T. (1991) American Journal
36, No. 19, pp. 285-289. of Infection Control, Vol 19, No. 1, pp 16-
4. Chen, S. Vesley, D. Brossuea, L.M., and 18.
Vincent, J. H. (1994) American Journal of 19. Beck W.C., (1952) American Journal of
Infection Control, Vol 22, No. 2, pp. 65 - Surgery. Vol 83, No. 2, pp 125 - 126.
74. 20. Belkin, N.L. (1999) The Guthrie Journal,
5. Skinner M.W. and Sutton, B.A.. (2001) Vol. 68, No. 1, pp 16-21.
Anesthesia and Intensive Care, Vol 29, No. 21. Brock.T, Madigan, M.T., Martinko, JM,
4, pp. 331-338 Parker, J. (1994) Biology of
6 Belkin, N.L., (1997). Infection control Microorganisms, Prentice Hall, New Jersey.
and Hospital Epidemlogy, Vol. 18, Iss. 1, 22. Wileke, K. Qian, Y., Donnelly, J.,
pp. 49-57 Grinshpun, S., Ulevicius, V. (1996),
7. Belkin, N.L., (1997). The Guthrie American Industrial Hygiene Association
Journal, Vol. 66, No. 1, pp. 32-34 Journal, Vol. 57, No. 4, pp 348 - 355.
Article Designation: Refereed 7 JTATM
Volume 3, Issue 2,Fall 2003
23. Qian, Y, Wileke, K., Grinshpun, S.A., American Industrial Hygiene Association
Donnelly, J., and Coffee, C.C. (1998) Journal, Vol. 59, No. 2, pp. 128-132.

Article Designation: Refereed 8 JTATM


Volume 3, Issue 2,Fall 2003

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